NCT01023958CompletedPhase 2
An Open-label, Single-arm, Phase II Trial of Intravenous BI 6727 in Patients With Locally Advanced, Metastatic or Recurrent Urothelial Cancer of the Bladder, Renal Pelvis, or Ureters After Failure of Prior Chemotherapy
Boehringer Ingelheim21 sites in 2 countries50 target enrollmentStarted: November 19, 2009Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 50
- Locations
- 21
- Primary Endpoint
- Objective Tumour Response According to RECIST Criteria
Study Overview
Brief Summary
The primary objective of this trial is to evaluate the efficacy and safety of BI 6727 in patients with locally advanced, metastatic or recurrent urothelial cancer after failure of first line or adjuvant/neoadjuvant chemotherapy.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
single arm
Experimental
open label
Intervention: BI 6727, IV infusion (Drug)
Outcomes
Primary Outcomes
Objective Tumour Response According to RECIST Criteria
Time Frame: From first drug administration until end of study, up to 2 years
Objective tumor response, defined as complete response (CR) or partial response (PR), according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.
Secondary Outcomes
- Cmax of Volasertib(5 mins before start of drug infusion and 2h, 3h, 6h, 24h, 168h and 336h after start of drug infusion)
- Duration of Overall Response(From the time of first response (CR or PR) to progression or death, up to 2 years)
- Disease Control Rate(From first drug administration until end of study, up to 2 years)
- Laboratory Investigation: Total Bilirubin(Baseline and last value on treatment (up to 2 years))
- AUC0-∞ of Volasertib(5 mins before start of drug infusion and 2h, 3h, 6h, 24h, 168h and 336h after start of drug infusion)
- Tmax of Volasertib(5 mins before start of drug infusion and 2h, 3h, 6h, 24h, 168h and 336h after start of drug infusion)
- Occurrence and Intensity of AE's Graded According to CTCAE(From first drug administration until end of study, up to 2 years)
- Laboratory Investigation: AST/GOT, SGOT(Baseline and last value on treatment (up to 2 years))
- Laboratory Investigation: ALT/GPT, SGPT(Baseline and last value on treatment (up to 2 years))
- Overall Survival(Time from first infusion to death, up to 2 years)
- Laboratory Investigation: Neutrophils(Baseline and last value on treatment (up to 2 years))
- Laboratory Investigation: Creatinine(Baseline and last value on treatment (up to 2 years))
- Progression-free Survival(Time from first treatment to the occurrence of tumor progression or death, up to 2 years)
- t1/2 of Volasertib(5 mins before start of drug infusion and 2h, 3h, 6h, 24h, 168h and 336h after start of drug infusion)
- CL of Volasertib(5 mins before start of drug infusion and 2h, 3h, 6h, 24h, 168h and 336h after start of drug infusion)
- Occurrence of Unacceptable Toxicity(From first drug administration up to 21 days after final administration, up to 2 years)
- Laboratory Investigation: Haemoglobin(Baseline and last value on treatment (up to 2 years))
- Laboratory Investigation: White Blood Cell Count(Baseline and last value on treatment (up to 2 years))
- Laboratory Investigation: Lymphocytes(Baseline and last value on treatment (up to 2 years))
- Laboratory Investigation: Alkaline Phosphatase(Baseline and last value on treatment (up to 2 years))
- Duration of Disease Control(Time of first response to progression or death, up to 2 years)
- Vss of Volasertib(5 mins before start of drug infusion and 2h, 3h, 6h, 24h, 168h and 336h after start of drug infusion)
- Laboratory Investigation: Platelets(Baseline and last value on treatment (up to 2 years))
Investigators
Study Sites (21)
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